article thumbnail

The Future for Biotesting

Pharmaceutical Technology

NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

In-Vitro 130
article thumbnail

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

This stage is more highly regulated and consists of both preclinical testing and clinical trials. Specific guidelines set forth to regulate these testing processes are issued by the ICH, a non-profit organisation with representation from global regulatory agencies and pharmaceutical companies. billion and take over 10 years.